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Session 8, Track B: Raising the Bar - Risk Based, Digitally Enabled PV Systems for Stronger Inspection Outcomes in LatAm
Session Chair(s)
Josefina Mendoza
PV Alliance LATAM, Head of PV CAMEX, LRP-PV CAM. Global Drug Safety, Grünenthal LATAM, Panama
Ana Paula Goncalves
Senior Director, Patient Safety Intercontinental, Bristol-Myers Squibb , Brazil
This session will examine the evolving landscape of pharmacovigilance inspections, audits, and inspection readiness across Latin America, with a focus on real-world impact rather than procedural checklists. Drawing on recent experiences from Health Authorities such as ANMAT, COFEPRIS, and ANVISA, the discussion will highlight common trends, inspection pain points, and expectations for both local and export markets. The session will also address the consequences of inspection findings in diverse regulatory environments and explore future directions, including digital systems, automation, and vendor oversight in emerging markets.
Learning Objective : At the conclusion of this session, participants should be able to - Analyze key trends and pain points observed in recent pharmacovigilance inspections in LatAm
- Evaluate risk-based strategies to strengthen inspection readiness beyond checklist compliance
- Identify expected organizational roles, digital capabilities, and vendor oversight practices during inspections
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